Psoriasis Clinical Trial
— IRISOfficial title:
Value Based Healthcare in Psoriasis - IRIS Trial
Rationale: Currently, the healthcare sector is under tremendous financial pressure, and many acknowledge that a dramatic shift is required as the current system is not sustainable. Furthermore, the quality of care that is delivered varies strongly. Several solutions have been proposed of which the conceptual framework known as value-based healthcare (VBHC) is further explored in this study for psoriasis. Psoriasis is a chronic inflammatory skin disease which is associated with high treatment costs. Objective: The objective of this study is to investigate the impact of using the VBHC framework for the management of psoriasis. Study design: The IRIS (value In psoRiasIS) study will be a prospective clinical trial in which new patients attending the psoriasis clinic (PsoPlus) of the Ghent University Hospital will be followed up during a period of 1 year. Study population: The study population consists of psoriasis patients attending the PsoPlus for the first time. Main study parameters/endpoints: The main outcome is to determine the value created for new psoriasis patients in PsoPlus over a period of 1 year. Thus, the main study parameters pertain to clinically and patient reported outcomes as well as the full cost for treating patients under the year of review, including referrals to other departments. Secondary outcomes are related to comorbidity control, individual outcomes and determining cost drivers. In addition, a bundled payment scheme should be determined as well as potential improvements in the treatment process.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | September 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Dermatologist reported diagnosis of psoriasis vulgaris - New patients that have never visited our specialized psoriasis consultation PsoPlus Exclusion Criteria: - Patients unable to provide consent - Patients who previously visited our specialized psoriasis consultation PsoPlus within the last 5 years - Patients who previously visited our psoriasis expert within the last 5 years - Patients with an uncertain diagnosis of psoriasis - Patients with all other subtypes of psoriasis - Patients who are unable to understand the tasks and questionnaires |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent | East-Flanders |
Belgium | University Hospital Ghent | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Janssen, LP, Novartis, Scientific Research Foundation-Flanders, Vlerick Business School |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the value created over a 1 year period while managing psoriasis patients within PsoPlus | The created value will be considered as a reflection of the evolution of the value score (i.e. the weighted outputs (outcomes in VOS) divided by weighted inputs (costs)) obtained using DEA | 1 year | |
Secondary | Outcomes | Determine change from baseline in VOS (all outcomes) at 6 and 12 months For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 6 and 12 months | |
Secondary | Outcomes | Determine the relationship between individual outcomes For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 6 and 12 months | |
Secondary | Outcomes | Determine variables (e.g. age, disease severity, treatment) that contribute to outcome variability For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 6 and 12 months | |
Secondary | Costs | Determine total costs at 6 and 12 months | At 6 and 12 months | |
Secondary | Costs | Determine variables (e.g. age, disease severity, treatment) that contribute to cost variability | At 6 and 12 months | |
Secondary | Outcomes/costs For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | Create patient profiles, that reflect efficient (experience more value) and inefficient (experience less value) patients, using DEA For a description of the VOS, see Detailed Study Description. | At 6 and 12 months | |
Secondary | Comorbidities | Assess the comorbidity evolution at 6 and 12 months (e.g. improvement (significant decrease) of cholesterol serum level) For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 6 and 12 months | |
Secondary | Comorbidities | Determine number of comorbidities controlled (treated and below cut-offs) at 6 and 12 months For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 6 and 12 months | |
Secondary | Comorbidities | Determine number of referrals to other specialists regarding comorbidities For a description of the VOS, see Detailed Study Description. The EQ-5D-5L will also be measured. | At 12 months | |
Secondary | Bundled payments | Determine a potential bundled payment scheme for treating different subsets of psoriasis patients over a particular time horizon | At 12 months | |
Secondary | Integrated Practice Unit | Improve the current IPU from an operational perspective by analyzing the value scores | At 12 months |
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